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APVMA REGULATORY GUIDELINES

Seeking comment on the APVMA draft regulatory guidelines

Available content:

Using the regulatory guidelines

Application types

Make an application

Information guidelines and standards

Monitoring and reporting

6A guidelines

Information and assistance

In response to feedback during consultation, the APVMA has generated a printable version

(PDF) of the regulatory guidelines to assist with review and preparation of submissions.

This product is only available during the consultation process.

The printable version is provided in seven parts, reflecting the primary headings used in the

website. It includes a table of contents to assist with navigating the document, however, the

functionality to click through to related content is not available.

To provide feedback on the regulatory guidelines, please reference the consultation page

number which appears above each section of content as follows:

The following content can be found at http://new.apvma.gov.au/node/XX

If making a submission, please reference page number: XX

Further information on the draft regulatory guidelines consultation can be found at:

www.apvma.gov.au/consultation/public/2014/regulatory_guidelines.php.

Submissions on the regulatory guidelines are invited to address comprehensiveness, readability,

errors, as well as usability of the website located at http://new.apvma.gov.au. Consultation closes

31 March 2014.

Disclaimer: the Commonwealth accepts no responsibility for the accuracy or completeness of any material

contained in this document. Material in this document is only guidance and is made available for the purposes

of consultation on the understanding that the Commonwealth is not providing professional advice. The full

disclaimer is available at http://new.apvma.gov.au/node/986

http://www.apvma.gov.au/consultation/public/2014/regulatory_guidelines.php

http://new.apvma.gov.au/

http://new.apvma.gov.au/node/986


APPLICATION AID 1

ALIGNING REGULATORY EFFORT WITH RISK 1

THE RESPONSIBILITIES OF MANUFACTURERS, IMPORTERS AND SUPPLIERS

OF AGVET CHEMICALS 2

Manufacturers of veterinary chemical products 3

Importers 3

Suppliers 4

THE ROLE OF THE APVMA 4

The APVMA‘s regulatory activities 5

Access to safe and effective agricultural and veterinary chemicals 5

What are ‘active constituents‘? 5

Agvet chemical product registration 6

Agvet permit approval 6

Ongoing compliance to ensure safety and efficacy 7

Compliance and enforcement 7

Reconsideration of approvals and registrations 8

Adverse Experience Reporting Program 8

Rights to review decisions 8

What information can the APVMA consider in an internal review? 9

APVMA decisions listed under section 167 of the Agvet Code that can be reviewed

by the AAT 10

The Record and Register 11

RISK MANAGEMENT 12

Conditions of approval or registration and label approval 12

Restricted chemical products 13

THE APVMA—A TRUSTED REGULATOR 15

Organization of economic cooperation and development 16

VICH 17

Joint FAO/WHO Meeting on Pesticide Residues 18

Joint FAO/WHO Expert Committee on Food Additives 18

Harmonisation 19

Collaborative and overseas assessments 19

The Rotterdam and Stockholm conventions 21

The Rotterdam Convention 21

The Stockholm Convention 22

APVMA STANDARD ON GOOD REGULATORY SCIENCE 23

Objective 23

Principles of good regulatory science practice 23

Quality assurance 23

Personnel and training 24

Standard operating procedures 24

Regulatory decision-making 24

Documentation of technical assessments 25

Advice from agencies, technical service providers and international sources 25

Quality control 25

Feedback and communication 26

APVMA DICTIONARY

Published on Australian Pesticides and Veterinary Medicines Authority(http://new.apvma.gov.au)

Home > PDF


An introduction to the regulatory guidelines and how they work, including information about theAPVMA—what we do and how we carry out our responsibilities. An application aid providesan overview of the decision-making process.

Application Aid

Intended to guide you through each step of the application process. It will also provide anestimate of the timeframe and the fee for an application. Available from 1 July 2014.

Intended to guide you through each step of the application process, the application aid willalso provide an estimate of the timeframe and the fee for an application. Available from 1 July2014.

Aligning regulatory effort with risk

The APVMA’s legislative framework provides for the consistency, efficiency and transparencyof agvet chemical approvals, registrations and reconsiderations, and helps us to align our

regulatory effort with risk. Section 1A of the Schedule to the Agricultural and Veterinary

Chemicals Code Act 1994 sets out the purpose and framework for regulatory decisionmaking for agvet chemicals.

This section highlights the importance of maintaining a balance between our regulatory effort,the regulatory burden imposed on those affected, and the risk associated with chemical use.

The following content can be found at http://new.apvma.gov.au/node/28If making a submission, please reference page number: 28




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http://www.comlaw.gov.au/Series/C2004A04723

http://www.apvma.gov.au/consultation/public/index.php



In administering the code, we aim to impose a regulatory burden in keeping with what isreasonably necessary to manage risks to the health and safety of human beings, animals andthe environment.

The legislative framework provides us with certain discretions—such as the extent to whichwe need to take into account particular matters in determining whether the efficacy and tradecriteria have been met. By allowing us these discretions, constrained within appropriate limitsby the Agvet Code Regulations, the framework makes us better able to match our regulatoryeffort with risk.

The statutory criteria that we will need to address in making regulatory decisions will includecriteria for safety, efficacy, trade and labelling. Currently, we align regulatory effort with riskthrough the use of modular applications and registration models, thereby allowing reducedregulatory effort on applications for the proposed use of active constituents, products andpermits that involve less risk.

Different product types give rise to risks and, as a result, the levels and types of assessmentrequired for us to be satisfied of the statutory criteria in registering a new product vary.Generally, lower risk products require reduced levels of assessment for us to be satisfied ofthe statutory criteria. For example, to satisfy the statutory criteria in registering a new product,we may (subject to limitations on use of information) be able to use a nominated referenceproduct that is very similar to the proposed product. This not only reduces our regulatory effortin determining whether the statutory criteria have been met, but also reduces the effortrequired by applicants to address the criteria.

The responsibilities of manufacturers,importers and suppliers of agvetchemicals

Before an agricultural or veterinary (agvet) chemical product can be legally imported,supplied, sold, promoted or advertised in Australia, the APVMA must register it (subject tocertain exceptions). Part of our role is to monitor and enforce compliance in the marketplacewith the regulatory requirements relating to agvet chemical products, and to helpmanufacturers, importers and suppliers of agvet chemicals to be aware of and have anunderstanding of these regulatory requirements.

We work closely with state and territory governments to ensure there is effective coordinationand communication of monitoring and compliance efforts. We also work with the AustralianCustoms and Border Protection Service to help stop the illegal importation of agvetchemicals.




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Manufacturers of veterinary chemicalproducts

The APVMA administers a Manufacturers’ Licensing Scheme where use of GoodManufacturing Practice (GMP) ensures that manufacturing processes are consistent, areunder adequate supervision, and have effective quality control.

Australian manufacturers of veterinary chemical products must be licensed by the APVMAthrough the Manufacturers’ Licensing Scheme before they can start manufacturing thoseproducts (subject to certain exceptions).

We will only issue licences to manufacturing facilities within Australia that have demonstratedcompliance with the Manufacturing Principles and the Australian Code of GoodManufacturing Practice for Veterinary Chemical Products. Facilities undergo audits toconfirm that they are compliant with these requirements before we issue a licence and atregular intervals while the licence is in force.

Because the Manufacturers’ Licensing Scheme applies only to manufacturers in Australia, wealso operate the Overseas GMP Scheme, which requires the manufacturing quality ofimported products to meet GMP standards equal to those applied to Australianmanufacturers. We assess overseas sites’ GMP compliance at the time an application ismade to us and as an ongoing activity over the life of the product.

If you are manufacturing a veterinary chemical product without the appropriate licence, youmay be committing an offence under the Agvet Code.

For further information on becoming a licensed manufacturer, refer to the licensing and GoodManufacturing Practice guidelines.

Importers

The APVMA monitors the importation of agvet chemicals to limit the potential distribution ofunregistered and unapproved chemicals in the Australian marketplace. Once an agvetchemical product is registered, persons must use these products and not attempt to importproducts with similar names registered for use in other countries. Such imported productsmay not be identical to the APVMA-registered products and are unlikely to carry the APVMA-approved label designed to meet Australian requirements for efficacy and safety.

We may, however, give consent in writing to a person who wishes to import a chemical

substance for which import would otherwise be an offence under the Agricultural andVeterinary Chemicals (Administration) Act 1992 (Admin Act).

You must not import an unregistered agricultural or veterinary chemical product or anunapproved active constituent into Australia, unless it has either been exempted from the


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importation provisions or the importer has obtained written Consent to Import from theAPVMA. Under special but limited circumstances, we may provide written Consent to Importto allow the import of unregistered agvet chemical products and unapproved activeconstituents.

If you have imported a product without our consent (and our consent was needed) and you donot have a reasonable excuse, you may have committed an offence under the Admin Act. Youmay also find you cannot clear the product through customs.

For further information on importing agvet chemicals, refer to the guideline on Consent toImport.

Suppliers

An agvet active constituent must be approved, or exempted from approval, by the APVMAbefore it can be supplied to the market.

An agvet chemical product must also be registered by the APVMA before it can be suppliedto the market (subject to certain exceptions). A product is considered an agricultural chemicalproduct or a veterinary chemical product if it meets the definition of an agricultural chemicalproduct or a veterinary chemical product. An agvet chemical product must also have anapproved label attached to it before it can be supplied to the market.

The APVMA maintains a public database (PubCRIS) where you can check whether an agvetchemical product is registered or an active constituent is approved. To find out if the productyou are supplying requires registration before it is supplied check the guideline: Does myproduct require registration?

If you supply an unapproved active constituent or a product that is not registered (where activeconstituent approval or product registration is required), or a product that has an unapprovedlabel attached and is not subject to an approved permit, you may have committed an offenceunder the Agvet Code.

The APVMA operates an Adverse Experience Reporting Program, which is a qualityassurance program established to facilitate the responsible management of agvet chemicalsthroughout their life cycle. If in supplying an agvet chemical you become aware of any adverseexperiences, you should report them to the APVMA.

The role of the APVMA

Find information on the APVMA's legislative framework (including the Agvet Code and the




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Regulations), what we do and how we administer the law. Provides information on how wemanage risks, as well as our standard of good regulatory science practice.

The APVMA's regulatory activities

Access to safe and effective agriculturaland veterinary chemicals

Australians need access to safe and effective agricultural and veterinary (agvet) chemicals tocontrol pests and diseases on animals and plants. Because of the potential risks from theincorrect use of agvet chemicals, the Australian Government has, for many years, played akey role in the regulation of pesticides and veterinary medicines. Regulatory measures are inplace to ensure these chemicals work, but are also safe for humans, non-target animals andplants, and the environment.

Agvet chemical products consist of one or more active constituents and may also containother non-active constituents (or excipients). The active constituents are responsible for thebiological or other effects of the product. The non-active active constituents are included for arange of reasons, such as stabilising the product, acting as a carrier for the active constituentor improving the properties of the product (for example, solubility or dispersion).

Under the existing national controls for agvet chemicals, it is a serious offence for any personto import an agvet chemical product into Australia or to distribute or sell a chemical product inany state or territory in Australia, if that product has not been registered by the APVMA forthat state or territory (subject to certain exceptions).

All active constituents for agvet chemical products must be approved by the APVMA (subjectto certain exceptions). It is a serious offence for any person to sell a chemical product thatdoes not have an APVMA-approved label attached to its container (subject to certainexceptions).

What are ‘active constituents’?

Active constituents are the substances in an agricultural or veterinary chemical product that





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are primarily responsible for the product’s biological or other effect identifying the product asan agricultural or veterinary chemical product (as the case may be). Generally, an activeconstituent must be approved either before or at the same time as the chemical productcontaining it is registered. A limited number of active constituents are exempt from APVMAapproval process or can be approved with the APVMA as the holder where informationneeded to register them is not readily available.

Agvet chemical product registration

If we decide to grant an application for registration of a chemical product and approve theproposed label, we must register the chemical product by entering certain information about itin the Register, and approve the label for the product by giving it a distinguishing number andrecording certain information about it in the relevant APVMA file.

Once a chemical product has been registered and its label approved, it can then be legallydistributed, sold and used in all Australian states and territories in which the product has beenregistered for use and which are described on the chemical product label.

If a holder later wants to vary any of the ‘particulars’ of registration as entered in the Registeror to make any variation to the approved label for the chemical product—including makingadditional claims about the chemical product—they will need to apply to us seeking approvalfor the proposed variations.

Registration ensures that users have access to chemical products that are correctlypackaged and labelled with all necessary limitations, precautions and directions for use.Registration of agvet chemical products also provides an assurance that these products aresafe and effective when used according to label instructions.

Registration also helps to ensure that unacceptable residues from the chemicals used inagriculture do not appear in food for human or animal consumption in Australia, or destinedfor export.

Agvet permit approval

The Agvet Code requires that all agvet chemical products sold in Australia be registered bythe APVMA (subjec to certain exceptions).

In most states and territories, registered chemical products must only be used for thepurposes specified on the label. However, in practice, situations often arise where chemicalproducts are needed for a use not specified on the label—‘off-label’ uses. We can considerapplications for permits that allow for the legal use of chemical products in ways different from




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the uses set out on the chemical product label. We can also consider applications for permitsallowing limited use of an unregistered chemical product.

In addition, we may issue a permit to persons (including individuals, organisations orcorporations) allowing them (or others) to use a particular agvet chemical product in a limitedway (that is, for minor uses, emergency uses or research purposes) when that chemicalproduct either is not registered or the proposed use is contrary to the use instructions anddirections on the approved label.

Ongoing compliance to ensure safety andefficacy

The APVMA has three primary post-authorisation (eg post approval or registration) programsto help ensure the ongoing safety and efficacy of agvet chemicals:

compliance and enforcementreconsideration of approvals and registrationsthe Adverse Experience Reporting Program.

Compliance and enforcement

Part of our role and responsibility is to monitor and enforce compliance with the Agvet Codeand other legislation we administer. We also work closely with state and territory governmentdepartments to ensure there is effective coordination and communication of complianceefforts.

We aim to maintain the integrity of the regulatory system, and focus our compliance andenforcement effort on activities that pose the greatest risk to human, plant or animal health,the environment, and trade.

In addition to conducting our own compliance campaigns, we encourage industry and thepublic to report the advertising and supply of unapproved active constituents andunregistered chemical products or the promotion of chemical products inconsistent withapproved labels. Upon receipt of a report, we prioritise it for appropriate action based on thelevel of risk.

Higher risk reports are pursued through an enquiry that may escalate to an investigation, witha view to compliance actions. The reports assessed as representing a low to medium, orcontinuing risk, are primarily dealt with through warnings and negotiation to achievecompliance.




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Reconsideration of approvals andregistrations

Reconsideration is a process that enables us to reconsider the approval of an activeconstituent, registration of a chemical product or approval of a label at any time after it hasbeen approved or registered, for example, if credible new information arises about theongoing safety, environmental impact or effects on trade of the product.

We take a wide range of scientific information into account when estimating potential riskbefore we register agricultural or veterinary chemical products. Nevertheless, sometimescredible new scientific information may emerge that suggests the existence of previouslyunknown risks to human health, animal or crop safety, the environment or trade, or suggestsproduct ineffectiveness. If this happens, we can initiate a reconsideration process to assessthe identified risk and determine whether changes are needed to ensure that the product cancontinue to be used safely.

Adverse Experience Reporting Program

The Adverse Experience Reporting Program assesses and classifies reports of adverseexperiences from exposure to, the use of, or the administration of a registered veterinary oragricultural chemical product sold in Australia when used according to label instructions. Thisprogram is vital for detecting uncommon conditions that are not evident and therefore notassessed during clinical or field trials for the initial APVMA registration of a product. It is alsoused for tracking the incidence of known adverse experiences from some products(particularly veterinary medicines).

Rights to review decisions

If you are unsatisfied with a decision made by the APVMA under the Agvet Code or the AgvetCode Regulations, you may be able to:

request that the APVMA reconsider the decision (that is, seek internal review) within 42days from the date that the decision was made (pursuant to section 166), orapply to the Administrative Appeals Tribunal (AAT) for review of the decision in












accordance with the provisions of the Administrative Appeals Tribunal Act 1975(pursuant to section 167).

We may only undertake an internal review of a decision if it falls within section 166(1) orsection 166(1A) of the Agvet Code.

Section 166(1) applies if:

a decision on a particular matter (the original decision) has been made under the AgvetCode or the Agvet Code Regulations on behalf of the APVMA by a staff member of theAPVMA, andthe person seeking the internal review is entitled to apply under section 167 of theAgvet Code to the AAT for review of the original decision.

Section 166(1A) applies if:

a decision on a particular matter (the original decision) has been made under the AgvetCode or the Agvet Code Regulations on behalf of the APVMA by a staff member of theAPVMA,the original decision is of a kind referred to in section 166(1A)(b) (generally, decision torefuse certain applications based only on requirements set out in sections 8A(a), 8A(b)or 122(1), as the case may be), andif the original decision were reviewable by the AAT, a person would be entitled to applyto the AAT for review of the original decision.

When we reconsider a decision, we must confirm, vary set aside the original decision, or setaside the original decision and make a new decision in substitution for the original decision.We must then notify the person who made the request of our decision on the reconsiderationas soon as practicable.

If we have not given notice on the internal review decision within 90 days after the requestwas made, the person who made the request may, by writing, notify us that they consider thatthe APVMA has confirmed the original decision at internal review.

The AAT may also review certain decision (that is, those set out in section 167 of the AgvetCode).

AAT review is not available for certain APVMA decisions, such as a decision to refusecertain applications based only on the requirements set out in sections 8A(a), 8A(b) or122(1), as the case may be).

Please note that reconsideration by the APVMA (that is, internal review) of a decision isdistinct from the reconsideration of approvals or registrations done under Division 4 of Part 2of the Agvet Code.

What information can the APVMA


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consider in an internal review?

If you make an application seeking an internal review of the a decision, we must reconsiderthat decision by having regard only to the information used to make that decision.

In an internal review, we will not consider further information or new information provided afterthe original decision is made.

While we are limited to only have regard to the original decision material, this does notprevent you from making a new application (where appropriate) if new information becomesavailable after the original decision in respect of the original application is made.

APVMA decisions listed under section167 of the Agvet Code that can bereviewed by the AAT

A decision under subsection 14(1) to approve or register a constituent, product or label:

(i) with an instruction or relevant particular other than an instruction or particular set outin the application for the approval or registration, or

(ii) subject to particular conditions.

A decision under subsection 14(2) to refuse an application for approval or registration,other than a decision based only on requirements set out in paragraph 8A(a) or (b).A decision under subsection 26C(2) to refuse an application to vary relevant particulars,other than a decision based only on requirements set out in paragraph 8A(a) or (b).A decision under subsection 29(2) to refuse an application to vary relevant particularsor conditions, other than a decision based only on requirements set out in paragraph8A(a) or (b).A decision under subsection 29D(3) to refuse to accept a late application.A decision under subsection 29G(1) to vary relevant particulars or conditions.A decision under subsection 34A(1) or 34AF(3) to vary relevant particulars orconditions.A decision (the information decision) under subsection 34J(3) that the APVMA issatisfied that it is in the public interest to use information that section 34G wouldotherwise prohibit the APVMA from using for making a decision (the substantivedecision):

(a) under section 14 or 29 about an application, or

(b) under section 34 about a reconsideration of an approval or registration. (But seebelow).


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A decision under section 34AA or Division 5 of Part 2 to suspend or cancel theapproval of an active constituent for a proposed or existing chemical product, theregistration of a chemical product or the approval of a label for containers for achemical product.A decision under subsection 48(3) refusing to accept a late application.A decision to use protected information under paragraph 59(2)(d).A decision under subsection 74(2), 75(2), 76(2) or 78(2) extending, or refusing toextend, a period.A decision under subsection 81(3) shortening, or extending or refusing to extend, aperiod.A decision under section 99 to require the analysis of a substance or mixture ofsubstances.A decision to issue a recall notice.A decision under Part 7 to refuse an application for a permit, other than a decisionbased only on requirements set out in paragraph 8A(a) or (b) or a requirement made bythe APVMA under subparagraph 111(1)(b)(iii).A decision under Part 7 to issue a permit subject to particular conditions or for aparticular period only.A decision under Part 7 to refuse to extend a permit other than a decision based onlyon requirements set out in paragraph 8A(a) or (b).A decision under section 118, 119, 119A or 119B to suspend or cancel a permit.A decision under Part 8 to refuse an application for a licence other than a decisionbased only on requirements set out in subsection 122(1).A decision under Part 8 to issue a licence subject to particular conditions referred to insubsection 126(1).A decision under subsection 126(2) to impose a new condition on a licence or varyingan existing condition.A decision under section 127 to suspend or cancel a licence.A decision to disclose information to an authority or organisation under paragraph162(3)(d) without the consent of the applicant or holder concerned.A decision to disclose information under section 163.A decision under subsection 164(8) to refuse to waive or remit the whole or a part of afee.A decision under this Code prescribed by the regulations.

Note that, despite paragraph 167(1)(ea), you may not apply to the AAT for review of theinformation decision if we stated in the notice of that decision given under section 34K thatwe believed it was necessary to make the substantive decision before 28 days had elapsedafter giving the notice, to prevent imminent risk to persons of death, serious injury or seriousillness.

The Record and Register

When an active constituent is approved, an agvet product is registered, or a label for an agvetproduct is approved, the APVMA records certain particulars (the relevant particulars) on:


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the Record of Approved Active Constituents for Chemical Products (the Record)the Register of Agricultural and Veterinary Chemical Products (the Register), orthe relevant APVMA file.

The Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and

Veterinary Chemicals Code Act 1994 requires us to keep the Record and Register in twoparts, one containing confidential commercial information and the other containing otherinformation. To support transparent and effective regulation, we make the components of theRecord and the Register that do not contain confidential commercial information publiclyavailable. The database comprising these components is called PubCRIS and is available onour website.

We also have a permits database, which lists minor use and emergency use permits that wehave issued. The database is publicly available on our website.

Risk management

The APVMA manages potential risks posed by agvet chemicals by, among other things,imposing conditions on approvals or registrations, and through requiring that certaininformation be contained on chemical product labels. Further, access to certain agvetchemical products is restricted if the Agvet Code Regulations declare them to be restrictedchemical products.

Conditions of approval or registrationand label approval

Under section 23 of the Agvet Code, approvals and registrations are subject to two types ofconditions: mandatory statutory conditions that apply in all cases of a particular kind (asprescribed by the Agvet Code Regulations), and the case by case conditions imposed on aparticular approval or registration as the APVMA thinks appropriate. Conditions of activeconstituent approval, chemical product registration, and label approval are a means by whichwe manage the risks posed to people, plants, animals and the environment by agvetchemicals.

The mandatory statutory conditions prescribed by the Agvet Code Regulations address thegeneral risks posed by all agvet chemicals. These conditions, together with our compliancemonitoring, reviewing and enforcement activities, ensure that people, plants, animals and theenvironment remain safe from agvet chemicals.

The case by case conditions address the specific risks associated with particular agvet









chemicals and will be imposed on approvals and registrations when we think it isappropriate. These conditions, together with our compliance monitoring, reviewing andenforcement activities, means that we are able to provide a higher level of assurance that therisk posed by these agvet chemicals will be better managed, which enables us to ensure thatpeople, plants, animals and the environment remain safe from agvet chemicals.

The conditions of approvals and registrations may require certain things to be done beforethe supply of an agvet chemical product occurs, to ensure the chemical product suppliedmeets the statutory criteria considered by the APVMA. For example, conditions may requirespecific types of packaging for products, or for labels to carry use-by dates.

In approving a label for a container for chemical products, we must be satisfied that the labelcontains adequate instructions. This allows us to ensure that the risks of using the agvetchemical product are adequately mitigated through appropriate instructions. Appropriateinstructions include:

circumstances in which the product should be usedhow the product should be usedtimes when the product should be usedfrequency of use of the productwithholding period after use of the productre-entry period after use of the productdisposal of the product when it is no longer requireddisposal of the containers of the productsafe handling of the product and first aid in the event of an accident caused by thehandling of the productthe appropriate signal words required by the current Poisons Standard.

The APVMA’s Argicultural Labelling Code and Veterinary Labelling Code also contain furtherlabelling requirements that further help in mitigating the risk of using agvet chemical productswhen used in accordance with the label instructions.

Restricted chemical products

Certain essential but inherently hazardous agvet chemical products may be declared by theAgvet Code Regulations to be restricted chemical products (RCPs). These products arestrictly controlled. RCPs can only be supplied to persons who are authorised to use theproduct under the laws of a state or territory. The relevant Australian state or territory authoritydetermines who may be considered as an ‘authorised person’, based on advice from theAPVMA following a risk assessment of the chemical product—these are people with specifictraining or qualifications in the safe handling and use of RCPs.

Australian state and territory authorities implement the RCP scheme through their respectivecontrol-of-use legislative frameworks by authorising persons to use RCPs once they havesuccessfully completed the relevant training and/or met other requirements.



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http://www.tga.gov.au/industry/scheduling-poisons-standard.htm




A chemical product may not be declared by the Agvet Code Regulations to be a restrictedchemical product unless the APVMA has certified in writing that it is in the public interest forthe product to be so declared. In deciding to give such a certificate, the APVMA must haveregard to the following:

whether the product may have an effect that is harmful to human beingswhether the product may have any unintended effect that is harmful to any animal, plantor thing or to the environmentwhether any special knowledge, skill or qualification is required in the preparation orhandling of the productwhether any special equipment is required to use the product with safety.

There are 11 chemical products or classes of chemical products which have been declaredto be restricted chemical products in Schedule 4 of the Agricultural and Veterinary

Chemicals Code Regulations 1995.

Table 1: Schedule 4—Restricted chemical productsNumber Restricted chemical products

1 A chemical product containing ethylene dibromide (also known as EDB)

2 A chemical product containing sodium monofluoroacetate (also known as 1080)

3 A chemical product containing acrolein

4A chemical product that is a pre construction termiticide product containingbifenthrin

5A chemical product that is a pre construction termiticide product containingchlorpyrifos

6 A chemical product containing endosulfan

7A chemical product containing pindone that is a concentrate and for which therelevant label instructions require further mixing with carriers before it is ready touse as a bait

8 A chemical product containing mevinphos

9A chemical product containing rabbit haemorrhagic disease virus (RHDV) (alsoknown as rabbit calicivirus) that is in injectable form and requires mixing withcarriers such as oats or carrot before it is ready to use as a bait

10A vertebrate pest control chemical product containing fenthion, alphachloraloseor 4 aminopyridine

11

All chemical products with formulations containing, as active constituents, all 3 ofthe following in various chemical forms:

(a) copper

(b) chromium

(c) arsenic


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http://www.comlaw.gov.au/Series/F1996B00288

Supplying restricted chemical products

A person must not supply a restricted chemical product, or cause or permit a restrictedchemical product to be supplied, to a person who is not authorised to use the product under arelevant state or territory law (that is, a person who is not authorised by a relevant state orterritory authority).

A person must not supply a restricted chemical products, or cause or permit a restrictedchemical product to be supplied, unless the label attached to the container for the productcontains the words:

RESTRICTED CHEMICAL PRODUCT—ONLY TO BE SUPPLIEDTO OR USED BY AN AUTHORISED PERSON

Becoming authorised to use the RCP

The requirements for a person to become authorised to use a RCP may vary across thestates and territories. For further information on state and territory control-of-use restrictionsfor RCPs, contact your relevant state or territory authority:

Australian Capital Territory—Environment and Sustainable Development DirectorateNew South Wales—Department of Environment and HeritageNorthern Territory—Department of Primary Industry and FisheriesQueensland—Department of Agriculture, Fisheries and ForestrySouth Australia—Biosecurity SATasmania—Department of Primary Industries, Parks, Water and EnvironmentVictoria—Department of Environment and Primary IndustriesWestern Australia—Department of Agriculture and Food.

The APVMA—a trusted regulator

Our vision is to be recognised nationally and internationally as a best-practice regulator ofpesticides and veterinary medicines that has the respect and confidence of governments, thecommunity, the rural sector, chemical users and the chemicals industry.

We are committed to continuous improvement, scientific excellence, innovation and being aworld class regulator of agricultural and veterinary chemicals.

To assist us to achieve our vision and maintain our contemporary scientific knowledge base,we:

engage with international agenciesadopt international guidelines when they are suitable for an Australian context



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http://www.environment.act.gov.au/

http://www.environment.nsw.gov.au/

http://www.nt.gov.au/d/

http://www.daff.qld.gov.au/

http://www.pir.sa.gov.au/biosecuritysa/ruralchem

http://www.dpiw.tas.gov.au/inter.nsf/Home/1?Open

http://www.dpi.vic.gov.au/

http://www.agric.wa.gov.au/


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are party to agreements with comparable overseas regulatory agencies.

The APVMA is frequently the lead agency on international working groups dealing with arange of regulatory issues involving pesticides and veterinary medicines. Our staff areregularly invited to speak at international conferences.

Organization of economic cooperationand development

The APVMA participates in various activities of the Organization for Economic Co-operationand Development (OECD), including the Working Group on Pesticides and Task Force onBiocides, Working Party on Manufactured Nanomaterials.

The Working Group on Pesticides is a committee that directs and oversees the work of theOECD Agricultural Pesticide Programme that encompasses agricultural pesticides. It iscomposed of government officials from OECD member countries, representatives from theEuropean Commission and other international organisations, observers from the pesticideindustry, and public interest non-governmental organisations.

The Pesticide Programme has three main objectives:

to help OECD governments share the work of pesticide registration and re-registration—the licensing of new products and re-licensing of old ones. This collaboration involvesfinding ways for governments to work together in assessing pesticide risks to humansand the environment. Work sharing is possible because the same pesticides are oftenused in many countriesto harmonise the data and methods used to test and assess pesticide risks.Harmonisation not only helps governments work together but also ensures the quality ofthe data and the rigour of the assessmentsto help OECD governments reduce the risks associated with pesticide use. Theprogramme identifies how governments can supplement pesticide registration andfurther reduce the risks that may result even when registered pesticides are usedproperly.

The Task Force on Biocides manages the work of the Biocide Programme including non-agricultural pesticides, and reports directly to the Joint Meeting of the Chemicals Committeeand the Working Party on Chemicals, Pesticides and Biotechnology.

The task force is composed of government officials from OECD member countries,representatives from the European Commission and other international organisations,observers from the pesticide industry, and public interest non-governmental organisations.

The OECD Working Party on Manufactured Nanomaterials concentrates on human healthand the implications for the safety of the environment posed by manufactured nanomaterials(limited mainly to the chemicals sector). The working party also aims to ensure that theapproach to the assessment of hazard, exposure and risk is of a high, scientifically-based,



http://www.oecd.org/env/ehs/pesticides-biocides/agriculturalpesticidesprogramme.htm


and internationally harmonised standard.

VICH

VICH (International Cooperation on Harmonisation of Technical Requirements forRegistration of Veterinary Medicinal Products) is a trilateral (European Union–Japan–UnitedStates) program that was established under the auspices of the World Organisation forAnimal Health to harmonise technical requirements for veterinary product registration.Australia, New Zealand and Canada have observer status on VICH.

The objectives of the VICH are:

to establish and implement harmonised regulatory requirements for veterinarymedicinal products in the VICH regions, which meet high quality, safety and efficacystandards and minimise the use of test animals and costs of product developmentto provide a basis for wider international harmonisation of registration requirementsto monitor and maintain existing VICH guidelines, taking particular note of theInternational Conference on Harmonisation work program and, where necessary,update these VICH guidelinesto ensure efficient processes for maintaining and monitoring the consistentinterpretation of data requirements following the implementation of VICH guidelinesby means of a constructive dialogue between regulatory authorities and industry, toprovide technical guidance for responses to significant emerging global issues andscience that affect regulatory requirements within VICH regions.

The APVMA supports the international harmonisation of requirements for data. The APVMAparticipates in the working process of the VICH Steering Committee, joins in Committeediscussions and provides experts where appropriate to the VICH Expert Working Groups.However, Australia’s observer status does not confer voting rights in the VICH process.

To date, the APVMA has adopted VICH guidelines on data requirements forchemistry, human safety (toxicology), environmental safety, anthelmintics andgood clinical practices.

Before adopting a VICH guideline, we ensure its suitability to Australian conditions. Thispractice reflects a principle in the APVMA Standard on Good Regulatory Science Practice—namely, that we will follow international, harmonised guidelines where it is possible orappropriate to do so.

When we adopt VICH guidelines that describe the global harmonisation ofregistration requirements, we minimise the use of test animals and the cost ofproduct development, and increase the availability of veterinary medicinalproducts in Australia.




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http://www.vichsec.org/




Joint FAO/WHO Meeting on PesticideResidues

The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) provides independent, expertscientific advice to the Codex Alimentarius Commission and its specialist committee onpesticide residues, the Codex Committee on Pesticide Residues (CCPR). The CodexAlimentarius Commission develops international food standards and guidelines, with the aimof protecting consumer health, ensuring fair trade practices and promoting coordination of allfood standards work undertaken by government and non-government organisations.

The JMPR comprises the World Health Organisation (WHO) Core Assessment Group andthe Food and Agricultural Organization of the United Nations (FAO) Panel of Experts onPesticide Residues in Food and the Environment. The WHO Core Assessment Groupundertakes toxicological reviews of pesticides and establishes health-based guidancevalues, such as acceptable daily intakes and acute reference doses, which in turn areimportant for establishing maximum residue limits (MRLs) used in international trade. TheFAO Panel reviews pesticide residue data, undertakes dietary risk assessments andrecommends to CCPR to be considered for adoption by the Codex AlimentariusCommission as Codex MRLs. APVMA scientists participate in both the WHO CoreAssessment Group and FAO Panel of Experts on Pesticides Residues.

In addition to its role in international standing-setting for pesticides, the JMPR also developsscientific guidelines on the interpretation of toxicological studies and advances pesticide riskassessment methodologies.

The toxicological and residues monographs published by the JMPR are an important sourceof information used by the APVMA.

Joint FAO/WHO Expert Committee onFood Additives

The APVMA actively participates in the Joint FAO/WHO Expert Committee on FoodAdditives, which is an international expert scientific committee administered jointly by theFood and Agriculture Organization of the United Nations (FAO) and the World HealthOrganization (WHO).

The committee has been meeting since 1956, initially to evaluate the safety of food. Its worknow includes the evaluation of contaminants, naturally occurring toxicants and residues ofveterinary drugs in food. To the end of 2012, the committee has evaluated the residues ofapproximately 95 veterinary drugs.

The committee has developed principles for the safety assessment of chemicals in foods that



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http://www.who.int/foodsafety/chem/jmpr/en/

http://www.fao.org/agriculture/crops/core-themes/theme/pests/jmpr/en/

http://www.who.int/foodsafety/chem/jecfa/en/


are consistent with current thinking on risk assessment and take account of developments intoxicology and other relevant sciences. We use the committee’s methodology to evaluateresidues of veterinary drugs in food to establish maximum residue limits.

Harmonisation

The APVMA actively participates in the harmonisation of data guidelines with ourinternational counterparts through organisations such as the Organization for Economic Co-operation and Development (OECD) and the International Cooperation on Harmonisation ofTechnical Requirements for Registration of Veterinary Medicinal Products (VICH).

We already align many areas of our guidelines with international standards; for example, theOECD guidelines for the testing of chemicals and VICH efficacy data. Hazard assessmentsare commonly shared internationally or worked on jointly, and are used to form the basis ofeach country’s risk assessment. The risk assessment then takes into account the country-specific uses of products and national policy approaches to the assessment of risks.

The alignment of Australian data guidelines with overseas regulators simplifies the assemblyand submission of dossiers by the chemical industry. The use of common internationalmethodology to assess data aligns the Australian evaluation with international best practiceand improves the consistency of decision making. The use of harmonised data guidelinesand assessment also promotes Australia’s ability to participate in international sharing ofwork and global joint reviews.

Our manufacturing requirements and standards are broadly comparable to other leadingcodes of good manufacturing practice such as the Pharmaceutical Inspection Convention andPharmaceutical Inspection Co-operation Scheme’s Guide to Good Manufacturing Practicefor Medicinal Products, 2009 and the World Health Organization’s Quality Assurance ofPharmaceuticals—A compendium of guidelines and related materials—Volume 2, Goodmanufacturing practices and inspection.

Collaborative and overseas assessments

The APVMA collaborates internationally to assess specific applications, and we may useoverseas assessment reports in work-sharing arrangements to support independent nationalrisk assessments.

For regulatory authorities, the various forms of sharing work can offer opportunities to makemore efficient and effective use of the specialist and expert resources needed to evaluate adossier. These arrangements may also benefit you in various ways, including:




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http://www.oecd.org/env/ehs/testing/seriesontestingandassessmentadoptedguidanceandreviewdocuments.htm


http://www.tga.gov.au/industry/manuf-pics-gmp-medicines.htm

http://apps.who.int/medicinedocs/en/cl/CL2.1.1.4.18/clmd,50.html




greater consistency and predictability in decision-making across regionsharmonised approaches to assessmentsingle dossier preparationcoordinated access to new markets.

You must propose the regulatory approach to the agencies involved and facilitate aspects ofthe planning and coordination of a global submission or work share.

Work-share arrangements do not affect our responsibility to conduct independent riskassessments and decision making. Our decisions may differ from those made in otherjurisdictions because we take the local conditions and use pattern into account.

International work sharing

International work-sharing arrangements are usually established on a case-by-case basisbecause the circumstances of each project are likely to vary. The primary element is thesharing of a hazard assessment report that is accompanied by the original data and takesinto account additional local information or data guidelines.

Global joint reviews of agricultural pesticides

A global joint review is the concurrent evaluation of a new pesticide or variations to aregistered pesticide product through a globally coordinated system of evaluations, peerreviews and report sharing. Countries take lead roles in the hazard assessments of proposedpesticides, and their reports are peer-reviewed by other participating countries. Thesereports are shared and used as the basis for each country’s own risk assessment anddecision-making, which may require the provision of data reflecting regional conditions anduse patterns. The global joint review process does not extend to evaluation of efficacy andwhere required each country undertakes its own independent evaluation.

The Organization for Economic Co-operation and Development (OECD) has established theframework for conducting the reviews in the Guidance document on the planning andimplementation of joint reviews of pesticides. This document includes detailed information onglobal joint review processes for applicants and regulatory authorities.

The consistent preparation of OECD-format dossiers by industry for submission in multipleOECD countries, the harmonisation of data requirements and the production of OECD-formatreports that can be easily shared among regulators form part of the OECD vision.

Since Australia completed its first global joint review of a pesticide dossier in 2007, we havecommitted to continued involvement in these applications.

For further guidance on work-sharing arrangements or collaborative and overseasassessments or to arrange for pre-application assistance meetings, please contact ourinternational coordinator.


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http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2011)11&doclanguage=en

http://www.oecd.org/chemicalsafety/agriculturalpesticidesandbiocides/oecdguidancedocumentsforpesticideregistration.htm


mailto:[email protected]?subject=Global%20joint%20reviews%20of%20agricultural%20pesticides



The Rotterdam and Stockholmconventions

In 2004, Australia became a party to two international agreements relating to the trade ofcertain hazardous chemicals:

Rotterdam Convention on the Prior Informed Consent Procedure for Certain HazardousChemicals and Pesticides in International TradeStockholm Convention on Persistent Organic Pollutants.

To implement these conventions, controls on the import, manufacture, use and export of suchchemicals have been introduced under the following legislation:

Agricultural and Veterinary Chemicals (Administration) Act 1992Customs (Prohibited Imports) Regulations 1956Customs (Prohibited Exports) Regulations 1958.

The Agricultural and Veterinary Chemicals (Administration) Act 1992 makes provisions forthe role of the APVMA in meeting Australia’s obligations under international agreements. Ourrole can include:

prohibiting the importing, manufacturing, exporting or other dealings of certainchemicals or products, or prohibiting certain activities in relation to these chemicals either absolutely or subject toconditions.

It also includes providing information to other countries on the importing, manufacturing,exporting or other dealings with other chemicals that are the subject of internationalagreements. These agreements include the Rotterdam Convention on the Prior InformedConsent Procedure for Certain Hazardous Chemicals and Pesticides in International Tradeand the Stockholm Convention on Persistent Organic Pollutants. The Customs Regulationscomplement the Agvet Code Regulations by introducing controls at the border. TheDepartment of Agriculture assists in managing these controls through its Livestock Industriesand Agvet Chemicals Branch.

The Rotterdam Convention

The Rotterdam Convention on the Prior Informed Consent Procedure for Certain HazardousChemicals and Pesticides in International Trade was adopted at a conference in Rotterdamin September 1998. The Australian Government ratified the Rotterdam Convention on 20 May2004, and obligations relating to the convention came into force for Australia on 18 August2004.

The Prior Informed Consent (PIC) procedure is a mechanism for formally obtaining and


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http://www.comlaw.gov.au/Details/C2012C00092

http://www.comlaw.gov.au/Details/F2008C00675

http://www.comlaw.gov.au/Details/F2009C00638

http://www.daff.gov.au/agriculture-food/ag-vet-chemicals/stockholm-rotterdam


disseminating the decisions of importing parties about whether they wish to receive futureshipments of those chemicals listed in Annex III of the convention and for ensuring compliancewith these decisions by exporting parties.

All parties are required to make a decision as to whether they will allow future import of eachof the chemicals in Annex III of the convention. All exporting parties are required to ensure thatexports of chemicals subject to the PIC procedure do not occur contrary to the decision ofeach importing party.

The Department of Agriculture will issue a notice in the Commonwealth of AustraliaAgricultural and Veterinary Chemicals Gazette when chemicals are added to the RotterdamConvention. Previous notices were issued on:

1 June 2004 27 April 201017 Aug 201020 Dec 201113 March 2012.

For the current chemicals included under the Rotterdam Convention, you should refer to theAnnex III Chemicals.

The Stockholm Convention

The Stockholm Convention on Persistent Organic Pollutants is a global treaty to protecthuman health and the environment from chemicals that remain intact in the environment forlong periods, become widely distributed geographically, accumulate in the fatty tissue ofhumans and wildlife, and have harmful impacts on human health or on the environment orboth.

Exposure to persistent organic pollutants (POPs) can lead to serious health effects includingcertain cancers, birth defects, dysfunctional immune and reproductive systems, greatersusceptibility to disease and damages to the central and peripheral nervous systems.

Control measures apply to the import, export, production, disposal and use of POPs.Participating governments also promote the best available techniques and bestenvironmental practices for replacing POPs while preventing the production and use of newones. The Australian Government ratified the Stockholm Convention on 20 May 2004, andobligations relating to it came into force for Australia on 18 August 2004.

For the current chemicals included under the Stockholm Convention, you should refer to theListing of POPs in the Stockholm Convention.




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http://www.pic.int/TheConvention/Chemicals/AnnexIIIChemicals/tabid/1132/language/en-US/Default.aspx

http://www.pic.int/TheConvention/Chemicals/AnnexIIIChemicals/tabid/1132/language/en-US/Default.aspx

http://chm.pops.int/Home/tabid/2121/mctl/ViewDetails/EventModID/9401/EventID/436/xmid/6921/Default.aspx

http://chm.pops.int/TheConvention/ThePOPs/ListingofPOPs/tabid/2509/Default.aspx




APVMA standard on good regulatoryscience

This APVMA standard sets out the principles of good regulatory science practice (GRSP) that we follow. The

standard is consistent with the principles described in other good practice standards, such as the standards for

good manufacturing practice, good laboratory practice and good clinical practice.

Objective

Compliance with the GRSP standard will strengthen the regulatory science quality thatunderpins our regulatory decisions. A working definition of regulatory science quality is:

Protecting the health and safety of people, animals and the environment andsupporting agricultural and livestock industries by making sound science-basedregulatory decisions regarding pesticides and veterinary medicines within aframework of accepted international risk assessment and risk managementpractices.

Science-based regulatory decisions are underpinned by a contemporary understanding ofscience, the identification and analysis of issues, the use of logic, and the documentation ofrisk assessment and risk management advice and decisions.

Principles of good regulatory sciencepractice

Quality assurance

The APVMA will maintain an externally audited and certified quality system.Our chief regulatory scientists will be responsible for the oversight of quality assuranceaspects of GRSP.All staff will have a responsibility for quality assurance, and team managers andexecutive directors will have line responsibility for the quality of work in their areas.




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Personnel and training

APVMA staff will receive training in the principles of GRSP relevant to their needs.Our staff will maintain relevant expertise as necessary, or the APVMA will accessrelevant expertise. Expertise will include knowledge of:

the objectives of regulation and the requirements of legislationrisk assessment and managementdata/studies being fit for purpose.

APVMA staff, agencies and advice providers will be appropriately involved in technicalassessments.There should be no gaps or unexplained or conflicting overlaps in the responsibilities ofthose concerned with GRSP.Key staff responsible for managing and supervising regulatory science quality will haveskills and experience to discharge the responsibility for ensuring that regulatorydecisions are underpinned by regulatory science quality.

Standard operating procedures

The APVMA will maintain key procedures and work processes, including for thepreparation and maintenance of documents, as part of its quality system, throughcompliance with ISO:9001:2000.Relevant key procedures and work processes will reflect or incorporate scientific andrisk analysis principles.

Regulatory decision-making

Decisions must be consistent with the APVMA’s governing legislation.Criteria for technical assessments are:

data received will be assessed for their fitness for purpose to ensure theirsuitability for evaluationrisk assessment procedures will be appropriate to the particular application beingconsidered and the level of risk involvedrisk management decisions will be based on risk assessment undertakenscientific issues will be addressed at the appropriate times during evaluation.





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The APVMA will identify the scientific criteria detailed in governing legislation and usethese in technical assessments that support regulatory decisions.

Documentation of technical assessments

Technical assessments will include a risk assessment and proposed risk managementstrategies.Technical assessments will be documented before regulatory decisions are made.Technical assessments will include sufficient detail, which is appropriate to the level ofrisk for the product group, risk area or issue.The level of risk for a particular product group or risk area will be reflected in technicalreports and written advice.Relevant legislative criteria will be identified and addressed in technical reports.

Advice from agencies, technical serviceproviders and international sources

Advice provided by agencies, technical service providers and international sources willbe critically considered prior to its use in regulatory decision-making.We may have regard to information and data from recognised international sourceswherever possible.Information from international sources will be determined to follow the same criteria asrequired of Australian information and data before its use by the APVMA.

Quality control

Different staff will be involved in the technical assessment and the final regulatorydecision-making where practical and/or appropriate.A more senior or experienced staff member will peer-review all technical assessments.





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Feedback and communication

The APVMA will develop and maintain regulatory guidelines.A comprehensive list of guidelines and a guidance agenda will be available in thepublic domain. The guidance agenda will list the guidelines that we are planningto develop during the financial year.We will follow international, harmonised guidelines where possible or appropriate.

We will use existing mechanisms for feedback from stakeholders on regulatory sciencequality.We will seek stakeholders’ views on a wide range of scientific regulatory issues, mostoften via the APVMA website.

APVMA dictionary

Definitions of legal, administrative and scientific/technical terms used in the regulatoryguidelines. Includes links to commonly used abbreviations and acronyms.

Definition of termsAbbreviations and acronyms


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http://new.apvma.gov.au/definition-of-terms

http://new.apvma.gov.au/abbreviations-and-acronyms


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Note: the APVMA dictionary is a stand-alone section of the regulatory guidelines that does not link through to other content. This content is not available in this PDF but may be reviewed online at: • Definition of terms: http://new.apvma.gov.au/definition-of-terms • Abbreviations and acronyms: http://new.apvma.gov.au/abbreviations-and-acronyms

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